A Pilot Study to Evaluate the Effect of Pomegranate Juice on Semen Parameters in Healthy Male Volunteers

NCT ID: NCT01595308

Last Updated: 2012-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-05-31

Brief Summary

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How daily consumption of pomegranate juice affects the concentration, morphology or motility of sperm in healthy men.

Detailed Description

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To determine, in this pilot study, whether daily consumption of pomegranate juice (POM) affects the concentration, morphology or motility of sperm in healthy men. The purpose of the present pilot study is to examine the hypothesis that POM may improve semen parameters in men.

Conditions

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Male Infertility

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pomegranate juice

Pomegranate juice

Group Type EXPERIMENTAL

Pomegranate juice

Intervention Type DIETARY_SUPPLEMENT

Pomegranate juice

Interventions

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Pomegranate juice

Pomegranate juice

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 12 healthy men aged 18-40
* normal sperm counts

Exclusion Criteria

* History of undescended testes or surgery to the scrotal contents,
* History of marijuana or alcohol abuse, hot tub usage at least 3 months prior to entry into the study
* No alpha adrenergic medications within two weeks of entry into the study,
* No anabolic steroid use,
* No anticholinergic or antimuscarinic drugs, use of colchicine, cimetidine, sulfasalazine, antipsychotics, antidepressants, immunosuppressive drugs prior use of any chemotherapeutic drugs, or UTI on screening visit.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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POM Wonderful LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jacob Rajfer, MD

Role: PRINCIPAL_INVESTIGATOR

Institute of Urologic Oncology at UCLA

Locations

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Clinical Trials Program at University of California

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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2010-002

Identifier Type: -

Identifier Source: org_study_id

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